Language for Consent Forms - New York University

New York University
University Committee on Activities Involving Human Subjects

665 Broadway, Suite 804, New York, NY 10012 ● VOICE: 212-998-4808 ● FAX: 212-995-4304 ● www.nyu.edu/ucaihs/

Language for Consent Forms

The purpose of the consent form is to give potential subjects a single document that includes all the
information they need to make an informed decision about participating in research and to indicate
their agreement to participate under the stated conditions.

The language below is intended to be used for all consent forms unless there is a specific reason for
differences; any changes should be justified in the application. Note that clinical trials, FDA, and
commercially sponsored studies require specific additional elements of consent or wording. These
are presented at the end of this document.

All consent forms should be:

• Printed on NYU Departmental letterhead.
• Clearly headed, e.g. Consent Form. If different forms will be used for different populations or

age groups, identify the group in the heading, e.g., Consent Form for Adults or Consent
Form for Minors 12-17 Years of Age. When the form is being developed for parents who
are not participating as subjects themselves, but only granting permission for a minor child to
participate in the research, it should be headed, Parental Permission Form. If a parent is
participating in the research as a subject (e.g., being interviewed, filling out a survey or
questionnaire), they should be given a separate form headed, Parental Consent Form.
• Written at no higher than a 10th grade level, using language appropriate for the sample
population (e.g., minors, speakers of English as a second language). Avoid technical
language or discipline-specific terms.
• Consistent about using “you” to refer to the subject, and the investigator’s name or “the
investigator” or “the researcher” to refer to the person carrying out the study.
• Designed to leave space (if appropriate) for material to be completed later, such as on-site
telephone numbers, date of focus group, etc. Do not use brackets or underlining.
• Designed so that the subject’s signature is not on a separate page from meaningful text.
• Single spaced using 11 or 12 point type with no more than 1” margins.
• Numbered in the format “page x of y” if the form is longer than two pages.

Be sure to check your Consent Form for the following:

• Spelling, typographical, and grammatical errors.
• Inclusion of full contact information (address, telephone number, email, and international

telephone codes if needed) for the investigator, the faculty sponsor, and the UCAIHS.
• All required signatures.

Note that shaded areas indicate the information specific to your study to be filled in. Page 1 of 4

05/12/08

Elements of Consent to Participate in a Research Study
Informed Consent

Who is doing what You have been invited to take part in a research study to learn more about [purpose of study]. This study
and why? will be conducted by [Principal Investigator (PI)], [PI’s NYU department & school], New York University.

If the investigator is a . . . as part of [his/her] [doctoral dissertation/master’s thesis work/etc.] [His/Her] faculty sponsor is [name
student or not an NYU of faculty sponsor], [NYU school/department/].
faculty member:

What will the subject be If you agree to be in this study, you will be asked to do the following:
asked to do (description [1. complete a questionnaire about your background (age, gender, education, etc.);
of procedures)? 2. take part in two interviews concerning [subject matter of interviews]; and
3. [continue description of procedures, if necessary.________________,]

If audio- or videotaping Your interviews will be audio- or video-taped.. You may review these tapes and request that all or any
will occur: portion of the tapes be destroyed. [In a group situation, add “that includes your participation.”]

How much time will
participation involve (total Participation in this study will involve [two hours of your time: 30 minutes to complete the questionnaire
number/approximate and approximately 45 minutes for each of the two interviews. The interviews will be held two weeks apart.]
length of sessions)?

Risks reasonably to be [There are no known risks associated with your participation in this research beyond those of everyday
expected & assistance life;.]
available, if needed
Or

[Although every effort will be made to prevent it, you may find the sensitive nature of some of the questions
upsetting. In that event, the investigator will provide you with a referral to a counselor with whom you may
discuss your feelings.]

Or

[There is a risk that you may have some muscle soreness for about four days.]

If there is more than Federal regulations require that all subjects be informed of the availability of medical treatment or
minimal risk and there is financial compensation in the event of physical injury resulting from participation in the research. New York
any possibility of University can not provide either medical treatment or financial compensation for any physical injury resulting
physical injury: from your participation in this research project.

Inquiries regarding this policy may be made to the principal investigator or, alternatively, the UCAIHS (212-
998-4808).

Benefits reasonably to Although you will receive no direct benefits, this research may help the investigator understand [refer to
be expected purpose of study] better.

(Please note: Incentives are not a benefit and should not be included as such.)

Fees or incentives, if any: [You will be paid $_______ for completing both interview sessions; if you withdraw before the end of the
study, [no payment/only partial payment of (amount)] will be given.] or [You will receive 1 hour of credit
towards your course requirement for completing both the surveys; if you withdraw before the end of the
study, [no credit/partial credit of (amount)] will be given.]

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Extent to which subject’s Confidentiality of your research records will be strictly maintained by [describe the specific ways to be used
confidentiality will be to protect subjects’ confidentiality (such as using codes or keeping consent forms separate from data to
maintained AND make sure that the subject’s name and identity will not become known or linked with any information they
have provided)].

If minors (< 18 years of Your responses will be kept confidential with the following exception: the researcher is required by law to
age) are involved, report to the appropriate authorities, suspicion of harm to yourself, to children, or to others.
mandated reporting

If applicable, for focus Your responses will be kept confidential by the researcher, but the researcher cannot guarantee that others
groups or group in the group will do the same.
interviews

Voluntary nature Participation in this study is voluntary. You may refuse to participate or withdraw at any time without
of participation/ penalty. For interviews, questionnaires or surveys, you have the right to skip or not answer any questions
right to withdraw or not you prefer not to answer.
to answer questions

If subjects are students, [Nonparticipation or withdrawal. . .
patients, clients, etc. will not affect your grades or academic standing. or
will not affect the services you receive at [name of agency, clinic, program, etc.].
will result in no loss of services to which you are otherwise entitled. or

Explanation & offer to If there is anything about the study or your participation that is unclear or that you do not understand, if you
answer questions have questions or wish to report a research-related problem, you may contact [investigator name] at [PI’s
For questions about phone number, e-mail, University address] or the faculty sponsor, [faculty sponsor name] at [faculty sponsor
subjects’ rights phone number, e-mail, University address].

For questions about your rights as a research participant, you may contact the University Committee on
Activities Involving Human Subjects, New York University, 665 Broadway, Suite 804, New York, NY 10012 at
212-998-4808 or [email protected] .

If subjects’ statements ___ Yes, I give the investigator permission to use my name when quoting material from our interview in
may be quoted, include his/her [dissertation, presentations, or publications] .
an attribution statement.
Copy of consent given ___ No, I would prefer that my name not be used.
to subject You have received a copy of this consent document to keep.

Subject’s agreement to Agreement to Participate
participate

Subject’s Signature & Subject's Signature Date
date

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If research is a clinical Additional Language
study:
These procedure differ from standard treatment in the following way(s), for example:
[1. a new drug/device/procedure will be used [describe]; or
2. an existing drug/device/procedure will be used in a new manner [describe];]

If there is a standard You could choose instead the following standard treatment: [describe].]
treatment other than that The drug/device/procedure is experimental and may not perform as well as the standard
offered in the study, add: drug/device/procedure, which is [describe drug/device/procedure].
If applicable for clinical
studies:

If the FDA is involved, Confidentiality of your research records will be maintained to the extent provided by law.
use this language for
the Confidentiality
Statement:

If the study is This study is sponsored by [company name], the maker of [the drug/device/procedure to be studied].
commercially
sponsored:

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